GILL-THOMAS-COSMAN(GTC) DENTAL TRAY— 510(k) K962155

Substantially Equivalent

Radionics Software Applications, Inc.

FDA 510(k) clearance K962155 for GILL-THOMAS-COSMAN(GTC) DENTAL TRAY, Substantially Equivalent on 1996-08-22. Applicant: Radionics Software Applications, Inc..

Clearance details

Applicant: Radionics Software Applications, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1996-06-04
Decision date: 1996-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.